An observational study in Anxiety, Panic Disorder and Mood Disorders, sponsored by University of Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by University of Toronto · Observational
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Among 21 studies in Panic Disorder with a site in Canada — 2 open to participants now, 5 under way, none of them phase 3. Panic Disorder · Canada.
Among the 21 studies in Panic Disorder with a site in Canada, this one is one of 2 that started in 2025, is one of 5 observational ones, and was the 21st registered.
270 studies on the registry are indexed under Panic Disorder; 37 are open to participants now.
Browse Panic Disorder studies →2 of the 21 studies in Panic Disorder with a site in Canada are open now. Recruiting first, the newest first:
Fraser Health · Sites in Canada
Ages 19+
University of Regina · Sites in Canada
Ages 19–57 · Healthy volunteers
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 24 Panic Disorder studies recruiting now, 8 (33%) set no upper age limit and 15 (63%) stop at 75 or younger; 6 take children under 18; 3 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 2 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 500 is above the median of 200 across 50 observational studies indexed under Panic Disorder.
Median enrollment 69 across the 16 interventional studies, 500 across the 5 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.
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None of the 21 has an industry lead sponsor. The 10 most frequent:
University of Toronto is the lead sponsor of 404 studies on the registry; 55 are open to participants now.
University of Toronto has 1 study filed under Panic Disorder — fewer than ten, so there is no comparison to draw.
1 of the studies in Panic Disorder with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06856161Fraser HealthA Novel Blood Test as a Biomarker in Mental Health | 2027-03-15 |
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Among the 21 studies in Panic Disorder with a site in Canada, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study aims to investigate the etiology of anxiety, depression, and panic disorders, providing new evidence and insights into the root causes and effective treatments, potentially offering a novel approach to achieving complete recovery.
Background: Anxiety, depression and panic disorders are among the most prevalent mental health conditions globally, affecting millions and imposing a substantial burden on individuals, families, and healthcare systems. These disorders often manifest through recurrent, severe episodes of anxiety and fear, frequently accompanied by physical symptoms such as palpitations, chest pain, and dizziness, which can lead to significant functional impairment and diminished quality of life. While current treatment options include pharmacotherapy and cognitive-behavioral therapy, response rates vary, and many patients experience residual symptoms or adverse effects, leading to high rates of treatment discontinuation. Furthermore, the growing recognition of treatment-resistant anxiety, depression and panic disorders highlights an urgent need for innovative, evidence-based therapies that provide sustained relief without compromising safety.
Introduction Anxiety, depression and panic disorders are pervasive and debilitating chronic mental health conditions, affecting approximately 20% of the global population over a lifetime. Characterized by episodes of intense fear and physical symptoms such as heart palpitations, shortness of breath, and dizziness, these disorders can severely impact daily functioning, interpersonal relationships, and overall quality of life. Individuals with these conditions are also at increased risk for comorbidities including depression, substance use disorders, and cardiovascular disease, further complicating their clinical profile and necessitating more comprehensive treatment strategies.
Despite the availability of pharmacotherapy, such as selective serotonin reuptake inhibitors (SSRIs) and benzodiazepines, alongside cognitive-behavioral therapy (CBT), there remain substantial challenges in achieving and maintaining symptom relief. Response rates vary widely, and a significant proportion of patients experience partial or inadequate relief, with some exhibiting treatment-resistant symptoms. Moreover, pharmacological treatments can be associated with side effects like weight gain, fatigue, and cognitive impairment, which may lead to discontinuation or non-adherence. These limitations highlight a critical need for alternative or adjunctive interventions that can provide more effective, sustainable, and safer outcomes.
This trial was therefore designed to assess the prevalence of pathogenic gut bacteria among patients with anxiety, depression, and panic disorder compared to healthy controls.
Objective: This study aims to investigate the etiology of anxiety, depression, and panic disorders, providing new evidence and insights into the root causes, potentially offering a novel approach to these conditions..
Findings from this study are anticipated to advance clinical understanding and treatment options for anxiety, depression and panic disorders, providing a potentially more effective approach and that provide lasting relief for patients struggling with these conditions.
270 studies on the registry are indexed under Panic Disorder; 37 are open to participants now.
This study's enrollment of 500 is above the median of 200 across 50 observational studies indexed under Panic Disorder.
Browse Panic Disorder studies →University of Toronto is the lead sponsor of 404 studies on the registry; 55 are open to participants now.
Compared within Panic Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The study population will consist of adult males and females aged 18 to 65 recruited from the general population and outpatient mental health clinics. Participants will include individuals with clinically confirmed anxiety, depression, or panic disorder, as well as healthy control subjects with no psychiatric history. The study will aim to include participants from diverse ethnic and cultural backgrounds to ensure broad representation of the population.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adults aged 18-65 years.
Either of the following:
Exclusion Criteria:
Diagnosis of psychotic disorders or neurocognitive conditions.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group are adults currently receiving ongoing treatment for anxiety, depression, or panic disorder. Treatment may include prescribed medication, psychotherapy, or other clinician-supervised care. These participants will complete the same baseline psychological assessments and stool microbiome testing as the other cohorts. Their data will help evaluate how existing treatments may influence gut microbiome composition and mental-health outcomes over time.
Diagnostic Test: H pylori stool test · Diagnostic Test: Bacterial stool analysis
Participants in this group are healthy adults with no self-reported or clinically diagnosed history of psychiatric or neurological disorders. They will complete the same baseline assessments and biological sample collection (including stool microbiome testing) as the clinical cohort, but will not receive any treatment or individualized intervention. Their data will serve as a comparison reference to help identify microbiome and biomarker patterns associated with anxiety and depression.
Diagnostic Test: H pylori stool test · Diagnostic Test: Bacterial stool analysis
Participants in this cohort are adults with a current, clinically confirmed diagnosis of anxiety disorder, depressive disorder, or panic disorder. Each participant will provide baseline psychological assessments and biological samples, including stool microbiome testing. Based on their results, they may receive individualized lifestyle or dietary recommendations under physician supervision. Participants will be followed over time to evaluate changes in mood, stress, and biological markers related to mental-health outcomes.
Diagnostic Test: H pylori stool test · Diagnostic Test: Bacterial stool analysis
Participants will provide a stool sample for noninvasive testing to detect the presence of Helicobacter pylori bacteria. The test will be performed using a validated laboratory assay that identifies H. pylori antigens in stool. Results will be used to assess potential associations between H. pylori infection, gut microbiome composition, and symptoms of anxiety or depression. The test is diagnostic only and does not involve administration of any drug or treatment.
Participants will provide stool samples for microbiome sequencing using a validated laboratory assay. The analysis will characterize bacterial taxa within the gut microbiome and identify potential pathogenic species. Sequencing results will be correlated with psychological assessments and clinical measures to investigate relationships between gut microbial composition and symptoms of anxiety, depression, and panic disorder.
Presence of pathogenic gut bacteria
The presence of pathogenic bacterial species will be identified through microbiome sequencing of stool samples using a validated laboratory assay. Sequencing data will be analyzed to detect and quantify bacterial taxa associated with dysbiosis and pathogenicity within the gut microbiome. The primary outcome will be defined as the detection of one or more bacterial pathogens meeting pre-specified taxonomic or functional criteria.
Time frame: Day 10 Upon receipt of stool analysis results
Symptom reduction, and eradication.
Changes in psychological symptom severity will be assessed using validated clinical instruments for anxiety, depression, and panic disorder. Composite symptom scores will be calculated and compared with baseline values to evaluate reductions in symptom severity over time. Correlations between the eradication of pathogenic gut bacteria and improvements in psychological symptoms will also be examined.
Time frame: Day 0 (baseline), Day 24 (post-eradication reassessment), and Day 30 (post-eradication reassessment)
Plan to share: No — Individual participant data will not be shared due to privacy considerations and data governance restrictions related to identifiable microbiome and psychological data. Summary results and aggregated findings will be made publicly available through publication and ClinicalTrials.gov reporting.
No publications or documents are linked to this record.
Ran from Dec 2025 to primary completion in Jan 2026, 1 month.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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